Medicine State control

Penn RG. The state control of medicines the first 3000 years. Br J Clin Pharmacol 1979 8 293-305. 

All the above-mentioned legal treatises apply to the European Economic Area (EEA this comprises the 27 EU member states plus Liechtenstein, Iceland, and Norway—Switzerland chose by referendum not to join the EEA, but has certain Swiss-EU bilateral agreements). Switzerland acts as the representative of the European Free Trade Association, which is an observer in the ICH (International Conference on Harmonization) process, accepts ICH guidelines, but is not part of the European Economic Area. There is a legal obligation for the Swiss competent authority, Swiss Agency for Therapeutic Products (Swissmedic), to take account of decisions/authorizations in other territories that have equivalent medicinal product control. 

Batches of medicinal products controlled in accordance with the requirements set out in No. 2 above in a Member State shall be accompanied by control reports signed by the person responsible. 

The medical profession also began to feel that the courts were interfering with the prerogatives of the doctor to treat his patient in a manner best suited to that patient s welfare. A new fear also began to emerge the country appeared to be moving toward state-controlled medicine and possibly compulsory health insurance. 

U.S. Laws and Regulations Related to Drug Product Development and Manufacture. Until early in the twentieth century, dmg products were made and sold in the United States having virtually no imposed control. QuaUty was generally poor. Many products were patent medicines of dubious value. Some were harmful and addicting. 

The approaches to analytical procedures uncertainty prognosis are developed. The correctness of these approaches is confirmed in 3rd and 4th rounds of pharmaceutical laboratories inter-laboratory testing ( Phamia-Test program of State Inspection for Quality Control of Medicines, Ministry of Health of Ukraine). 

Many medicines contain a wide variety of ingredients, often in quite complex physicochemical states, included to create formulations which are efficacious, stable and sufficiently elegant to be acceptable to patients. Should microbial contaminants survive manufacture, or enter during storage or use they are likely to meet conditions which are often conducive to survival and even replication of an appreciable assortment of non-fastidious bacteria, ftingi and yeasts, and microbial spoilage may ensue unless steps are taken to control it. Microbial spoilage may include ... 

The first Venezuelan dmg law, the Ordinance of the Council of Physicians and Secret Medicines and Patents (1883), stated its objective as the control and registry of medicines, in order to develop a pharmacopoeia of dmgs with established pharmacological properties, composition, indication and dosage, for the purposes of standardization. A product registration system was developed and the DRA was created some decades later. 

Just like all herbal medicinal preparations, C. sativa should be standardized if extracts or whole plant material are to be used for medicinal purposes. Basic requirements are that all detectable constituents should be known, but also a sustainable quahty control system must be established to achieve the same quahty over all batches. For industrial use of cannabis, standardization could also be necessary to equahze the quality of the product. However, it must be stated that cultivation for this purposes is mostly performed outdoors. Outdoor growth makes standardization of the product difficult due to the environmental changes. For this reason the Dutch medicinal C. sativa is grown under strictly controllable conditions, and therefore indoors, by the company Bedrocan. At this company clones are used for breeding to maintain high standards for quantity and quality. After a strictly selective breeding procedure a plant fine has been estabhshed fulfilhng all criteria as a herb for medicinal use. 

The regulation also stipulates that a maximum of three courses of treatment with chemically synthesised allopathic veterinary medical products or antibiotics within one year (or no more than one course of treatment if the productive life cycle is less than one year) is acceptable. These regulations are designed to encourage the use of preventive management and alternative treatments for the control of parasites and diseases. Vaccinations, veterinary medicine treatments for parasites and any compulsory eradication schemes established by Member States are exempt from the treatment maximums, in order to ensure animal welfare. 

---